Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID06529848

Ischemia With No Obstruction of Coronary Arteries: Underlying Mechanisms and the Impact of Exercise Training (EXINOCA)

Led by Bispebjerg Hospital · Updated on 2025-02-21

100

Participants Needed

2

Research Sites

28 weeks

Total Duration

On this page

Sponsors

B

Bispebjerg Hospital

Lead Sponsor

U

University of Copenhagen

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates coronary microvascular dysfunction (CMD) in patients experiencing chest pain without narrowing of the heart's coronary arteries, a condition known as ischemia with no obstructive coronary artery disease (INOCA). The study explores whether this reduced microvascular function also affects other body organs and whether regular aerobic exercise can improve this heart condition and symptoms. The trial aims to better understand CMD mechanisms and assess exercise training effects in these patients. Participants will be randomly assigned to one of two groups: an exercise training group or a control group. The exercise group will engage in supervised cycling sessions lasting 40-50 minutes, three times weekly for 12 weeks. These sessions include warm-up, interval cycling at varying intensities, and cool-down phases, with progressive intensity throughout the program. Home training up to once weekly is allowed if intensity levels are maintained. The control group will not receive training during the study but will be offered exercise afterward. Participants are encouraged to maintain their usual lifestyle and medications. During the study, researchers will monitor changes in coronary microvascular function using myocardial blood flow reserve measurements before and after three months. They will also assess symptoms using angina questionnaires, exercise capacity, and blood flow in skin, muscle, and fat tissue. Training sessions are closely supervised with heart rate and exertion monitoring to ensure safety and effectiveness. The total participation duration includes the 12-week intervention period with assessments at baseline and after three months.

CONDITIONS

Brief Title

Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Coronary microvascular dysfunction defined by myocardial blood flow reserve (MBFR) below 2.5 or hyperemic myocardial blood flow below 2.3 ml/g/min using [15O]H2O-PET
  • No obstructive coronary artery disease
  • Adults aged 50 years or older
  • Female participants must be postmenopausal (amenorrhea for at least 1 year) or surgically sterile
Not Eligible

You will not qualify if you...

  • Females of childbearing potential who are premenopausal and capable of becoming pregnant
  • Heart failure with left ventricular ejection fraction less than 40%
  • Uncontrolled hypertension with blood pressure above 140/90
  • Co-morbid conditions leading to less than 1 year expected survival
  • Considered unsuitable for the study by the investigator for any reason
  • Unable or unwilling to exercise due to conditions like arthritis or injury
  • Already regularly physically active or have maximal oxygen uptake greater than 45 ml/kg/min

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 weeks

Participants undergo supervised exercise training consisting of cycling sessions 40-50 minutes, 3 times weekly for 12 weeks. Home training once a week is allowed if participants can maintain prescribed intensity levels.

3 visits per week (supervised cycling sessions) with additional home training up to once a week

Trial Site Locations

Total: 2 locations

1

Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000

Copenhagen, Denmark, 2400

Not Yet Recruiting

2

Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57

Frederiksberg, Denmark, 2000

Actively Recruiting

Loading map...

Research Team

E

Eva Prescott, MD, DMSc

M

Mads Fischer, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Clinical Study of Fundus Optical Coherence Tomography Angi...

Coronary Microvascular Disease

Actively Recruiting

1 location

China Coronary Microvascular Disease (CCMD) Registry

Coronary Microvascular Disease

Actively Recruiting

1 location

Barts Myocardial Infarction With Non-Obstructed Coronary Art...

Myocardial Infarction

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here